Intervention Summary

Healthy Living Project for People Living With HIV

The Healthy Living Project for People Living With HIV promotes protective health decisionmaking among individuals with HIV--heterosexual women, heterosexual men, gay men, and injection drug users--to reduce substance use and the risk of transmitting HIV. The Healthy Living Project is based on social action theory and targets the interactive psychosocial domains of the community environment, internal affective states, and self-regulation. Using a cognitive-behavioral approach, this manual-driven intervention is delivered by facilitators functioning as "life coaches" who work with clients individually to help them make changes in their health behavior, become active participants in their ongoing medical care, and achieve desired personal goals. The Healthy Living Project consists of 15 sessions, each 90 minutes in duration, presented in 3 modules: Stress, Coping, and Adjustment; Safer Behaviors; and Health Behaviors. During tailored counseling sessions, the client is encouraged to identify a life project and work with the coach to set attainable goals and build self-confidence, self-esteem, and motivation to increase protective health behaviors. Intervention strategies include psychosocial education, skills building to improve coping, and problem-solving training involving role-play exercises.

Since 2000, the intervention has been implemented at four sites in three States (California, New York, and Wisconsin) with at least 936 HIV-positive clients, as well as in China.

NIH Funding/CER Studies

Partially/fully funded by National Institutes of Health: YesEvaluated in comparative effectiveness research studies: No

Adaptations

The intervention has been adapted and translated for use in China.

Adverse Effects

No adverse effects, concerns, or unintended consequences were identified by the developer.

IOM Prevention Categories

Indicated

Quality of Research

Review Date: March 2010

Documents Reviewed

The documents below were reviewed for Quality of Research. The research point of
contact can provide information regarding the studies reviewed and the availability
of additional materials, including those from more recent studies that may have been conducted.

Outcomes

Outcome 1: Substance use

Description of Measures

The substance use measure was derived from scales used in the 1999 National Survey on Drug Use and Health (NSDUH). It measured self-reported days in the past 3 months that the client used each of the following substances: alcohol, barbiturates, cocaine/crack, gamma-hydroxybutyrate (GHB), hallucinogens, heroin, inhalants, ketamine, marijuana, 3,4-methylenedioxymethamphetamine (MDMA, or ecstasy), methadone, opiates, sedatives, speedballs, steroids, and stimulants (i.e., methamphetamine/amphetamine). Interviews were conducted in private settings on laptop computers using an audio computer-assisted self-interviewing format. The TimeLine Followback (TLFB) method was used to solicit information about use of each substance. The TLFB method uses a calendar to help the respondent reconstruct prior days of drinking and drug use over a specified time period.

Reported days of use for each substance were rated on a 9-point categorical scale developed by researchers for use in this study: 0 (never), 1 (less than once per month), 3 (once per month), 7 (2-3 times per month), 12 (once per week), 30 (2-3 times per week), 60 (4-6 times per week), 90 (once per day), and 120 (more than once per day). Each substance was also assigned a severity rating according to a 5-point categorical scale developed by researchers for use in this study: 0 (none); 1 (alcohol); 2 (marijuana); 3 (barbiturates, methadone, inhalants, sedatives, and steroids); and 4 (cocaine/crack, GHB, hallucinogens, heroin, ketamine, speedballs, MDMA, opiates, and stimulants). The ratings for days of use and severity of the substance provided a weighted index for days of use by drug severity.

Key Findings

In a randomized clinical trial, HIV-positive clients undergoing outpatient medical care were assigned to an intervention group receiving the Healthy Living Project or to a wait-list control group. Assessments occurred at baseline and at 5-month intervals up to 25 months after randomization. Among the findings from this study were the following:

Compared with the control group, the intervention group reported fewer days using alcohol, marijuana, methadone, inhalants, MDMA, stimulants, sedatives, barbiturates, steroids, heroin, cocaine/crack, and speedballs across the follow-up period (p < .0001).

Compared with the control group, the intervention group reported fewer days of any substance use across the follow-up period (p < .0001).

Among the 35% of clients who were homeless or marginally housed, those in the intervention group reported fewer days using alcohol or marijuana (p = .002) and fewer days using hard drugs (i.e., heroin, cocaine/crack, speedball, MDMA; p = .042) across the follow-up period compared with those in the control group.

Across the follow-up period, the intervention group had greater declines than the control group in the weighted days of use by drug severity index for alcohol, marijuana, methadone, inhalants, MDMA, stimulants, sedatives, barbiturates, and steroids (p < .0001) but not for heroin, opiates, cocaine/ crack, ketamine, GHB, or hallucinogens.

Across the follow-up period, women in the intervention group reported fewer days of substance use than women in the control group and men in either condition for alcohol, marijuana, methadone, inhalants, MDMA, stimulants, sedatives, barbiturates, steroids, heroin, cocaine/crack, and speedballs (p < .0001). Additionally, women in the intervention group had larger declines than women in the control group and men in either condition in the weighted days of use by drug severity index for all substances but heroin, cocaine/crack, and speedballs across the follow-up period (p < .0001).

Men in the intervention group reduced their days using alcohol, marijuana, stimulants, and any substances more than men in the control group (p < .0001) and showed a larger decline in the weighted days of use by drug severity index for alcohol and marijuana (p < .0001) across the follow-up period.

Heterosexual men in the intervention group reduced their days of stimulant use more than heterosexual men in the control group (p < .0001) and gay men in either condition (p = .03) across the follow-up period.

Gay men in the intervention group reported fewer days of hard drug use than gay men in the control group (p < .04) and more days of hard drug use than heterosexual men in either condition (p = .0002) across the follow-up period.

HIV sexual risk behaviors were measured as the number of self-reported unprotected sexual acts in the past 3 months with a partner whose HIV serostatus was negative or unknown to the client. An unprotected sex act was defined as any act of insertive or receptive anal or vaginal intercourse in which neither party used a condom. Interviews were conducted in private settings on laptop computers using a combination of audio computer-assisted self-interviewing and computer-assisted personal interviewing.

Key Findings

In a randomized clinical trial, HIV-positive clients undergoing outpatient medical care were assigned to an intervention group receiving the Healthy Living Project or to a wait-list control group. Assessments occurred at baseline and at 5-month intervals up to 25 months after randomization. Among the findings from this study were the following:

From months 5 to 25 of follow-up, the number of self-reported unprotected sexual acts steadily declined for the intervention group compared with the control group (p = .0069), after controlling for baseline group differences in the number of unprotected sexual acts.

Clients in both conditions reported reductions in the number of unprotected sexual acts from baseline through the follow-up period (p < .0001). At the 20-month follow-up, however, intervention clients reported 36% fewer unprotected sexual acts than those in the control group (p = .007).

Among the 35% of clients who were homeless or marginally housed, intervention clients reported fewer sexual partners who were HIV-negative or of unknown serostatus (p < .001) and fewer unprotected sexual acts (p = .037) across the follow-up period compared with control group clients.

Quality of Research Ratings by Criteria (0.0-4.0 scale)

External reviewers independently evaluate the Quality of Research for an intervention's
reported results using six criteria:

Reliability of measures

Validity of measures

Intervention fidelity

Missing data and attrition

Potential confounding variables

Appropriateness of analysis

For more information about these criteria and the meaning of the ratings, see Quality of Research.

Outcome

Reliability
of Measures

Validity
of Measures

Fidelity

Missing
Data/Attrition

Confounding
Variables

Data
Analysis

Overall
Rating

1: Substance use

3.5

3.0

3.5

4.0

3.5

4.0

3.6

2: HIV sexual risk behaviors

4.0

3.5

3.5

4.0

3.5

4.0

3.8

Study Strengths

The substance use outcome measure is considered the gold standard for self-reports. Sample reliability was provided for the measure of HIV sexual risk behaviors, and prior research has documented the reliability of computer-delivered interviews for reporting behaviors of a sensitive nature. Treatment fidelity was strong in this study, which used a detailed manual, systematic training, and an adherence instrument. Missing data rates were low, and data that were missing were well managed with an intent-to-treat statistical approach and sophisticated data modeling. The study design included random assignment to conditions and a large sample size that provided statistical power to detect outcome differences between conditions. A sophisticated data analysis approach was used.

Study Weaknesses

No biological measure such as urinalysis was used to strengthen the internal validity of self-reported drug use. Similarly, the validity of self-reported sexual behavior is an issue in this type of sensitive research; underreporting, both at pretest and follow-up, cannot be ruled out. As a result of minor problems with implementing random assignment, 9% of the study sample participated in the group to which they were not assigned.

Readiness for Dissemination

Review Date: March 2010

Materials Reviewed

The materials below were reviewed for Readiness for Dissemination. The implementation
point of contact can provide information regarding implementation of the intervention
and the availability of additional, updated, or new materials.

Dissemination Strengths

The materials include a series of highly detailed, well-developed guides and manuals to support implementation, and the role of the facilitator is clearly articulated. Customized training and telephone and email consultation are available for a fee. A well-developed quality control manual includes quality assurance checklists and screening criteria for both participants and program facilitators. A comprehensive data collection and data management system is also available to support quality assurance.

Dissemination Weaknesses

Implementation materials and quality assurance tools have not been adapted for use outside a research setting. The training and support offered are not formalized.

Costs

The cost information below was provided by the developer. Although this cost information
may have been updated by the developer since the time of review, it may not reflect
the current costs or availability of items (including newly developed or discontinued
items). The implementation point of contact can provide current information and
discuss implementation requirements.

Item Description

Cost

Required by Developer

Intervention manual and other implementation materials

Free

Yes

2-week, onsite training

$1,300 per participant plus travel expenses

Yes

30-minute phone consultation before training or implementation

Free

No

Intervention quality assurance and quality control manual and other quality assurance materials

Free

No

Technical assistance/consultation

$50 per hour by phone

No

Additional Information

The estimated cost for delivering the program to one client is $412. Implementers should have a bachelor's degree, and program trainers must be experienced in behavioral management approaches.